Critikon Company, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
51
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K002248DINAMAP PRO 1000 MONITOR, MODEL 1000September 21, 2000
K000500DINAMAP ADVANCED NIBP MODULEMay 26, 2000
K992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400February 24, 2000
K982342DINAMAP MPS SELECT PORTABLE MONITORAugust 14, 1998
K943709DINAMAP PLUS VITAL SIGNS MONOITORJune 16, 1995
K942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340March 1, 1995
K933404CRITIKON CENTRAL STATIN MONITORFebruary 9, 1994
K933050CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATHDecember 14, 1993
K915697CRITIKON VITAL SIGNS MODULEJuly 1, 1993
K921295INTRAVENOUS CATHETERS MODIFICATIONSMay 17, 1993
K912188DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700December 4, 1991
K911769RATEMINDER(TM) V INFUSION PUMP, MODIFICATIONJune 3, 1991
K902092RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITYJuly 26, 1990
K894100OXYTRAK(TM) PULSE OXIMETERMay 9, 1990
K893546OPTICALLY CLEAR RADIOPAQUE CATHETERNovember 1, 1989
K874546SIM MODULEMay 11, 1988
K875174RATEMINDER V INFUSION PUMPMarch 29, 1988
K874442DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETERFebruary 18, 1988
K875177J&J SCALP VEIN INFUSION SETSJanuary 14, 1988
K874378DINAMAP VITAL SIGNS MONITOR, MODEL 8100TDecember 30, 1987